Risultati di uno studio randomizzato singolo cieco placebo versus Diallil-Tiosulfinato, Nuciferina e Diosgenina in pazienti responders a Tadalafil 5 mg; Results of a single blind study placebo vs Diallil-Tiosulphinate, Nucipherine and Diosgenin in patients reponders to Tadalafil 5 mg

Abstract

The aim of the study is to evaluate the efficacy of Diallil-Tiosulphinate, Nuciepherine and Diosgenin in the treatment of erectile dysfunction. In our study were selected 120 men affected by erectile dysfunction. They were filled in a self-administered questionnaire International Index of Sexual Medicine. 74 of them reported a moderate erectile dysfunction and 46 reported a severe ED. All patients were treated with Tadalafil 5 mg once a day for 90 days. They were re-evaluated with the same questionnaire after three months of therapy. In 75% of the patients there was an improvement of IIEF-5 score. Only the 90 patients responders to Tadalafil once a day were randomized and divided into two groups, each formed by 45 subjects. The group A was treated with the association of Diallil-Tiosulfinate, Nucipherine and Diosgenin on alternate days. The patients of group B were treated with placebo. After three months, there was a new evaluation with IIEF-5 score. In group A we reported a maintenance of improvement post-Tadalafil in 36 patients;in group B, only 18 patients have maintained the previous improvement, according to IIEF-5 score. The χ2 test is 13,38, with a p-value of about 0,00013.The maintenance’s odds ratio, confronting the two groups, is 6 with a confidence’s interval of 95%. The study shows that the utilization of the association therapy in patients with erectile dysfunction responders to Tadalafil once a day is able to duplicate the odds of maintenance’s improvement compared to placebo.